Having the right resources at the right time is critical to a clinical trial’s success, and no resource is more valuable than a site’s staff. But the uncertainty about future needs caused by the current pandemic makes it difficult to plan for the right staff mix and scheduling. 

And with sites looking forward to reopening when the worst of the COVID-19 pandemic has passed, that kind of planning is vital. The coming months will see a “huge crunch” on site staff, said Michael Cioffi, senior vice president for clinical solutions and strategic partnerships at WCG Clinical, in the July 2020 issue of The CenterWatch Monthly.¹

Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP) said in the same article that he fears that some sponsors and CROs may be underestimating the challenges that clinical trials are facing as they try to restart operations. “A lot of sites had to furlough people, or in some cases, even lay people off. So they’re not going to have the same capacity right off the bat,” he says.

Indeed, clinical trials already have reported constrained personnel resources due to COVID-19. Boston-based Halloran Consulting Group CEO and President Laurie Halloran says in an April 2020 article in Clinical Leader that sites have struggled with shortages as staff members have been pulled away to help other COVID-19 efforts.² 

Clinical research sites aiming to restart their trials may be overwhelmed with handling the normal operations of business as well as patient and staff protections during a pandemic, according to Halloran. 

Planning for staffing needs should start now, said Alison Lakin, associate vice chancellor for regulatory compliance at the University of Colorado’s Anschutz Medical Campus, at an April WCG Clinical webinar. “I think now is actually the right time to be strategically thinking about how we efficiently, collaboratively and in a coordinated manner move forward with research, managing the safety as well as the clinical trial interests.”³

Site capacity will vary as trials come back online, Lakin said, because the pandemic may affect different sites and different regions in different ways. Basic resources, such as access to pharmacy services and radiologic procedures, may be limited because of reallocation to clinical care. Even personnel availability may be limited, she said. Reassignment of clinical trial staff to clinical care may continue, and researchers in such specialty areas as pulmonary, infectious disease, surgery and anesthesiology may have limited capacity.

 “Things are very different from the way that we were working in January or February of 2020,” says Kathryn King, senior vice president of clinical development for Aptinyx. King told listeners at the same webinar that one lesson learned from the crisis is that work-from-home arrangements can be productive. Sponsors should “support and leverage” work from home. Even after the pandemic has passed, unexpected events — or even a resurgence of the virus — could keep staff from getting to their sites. 

Another tactic for covering the potential unavailability of team members is assigning back-ups for key trial processes, King said, including such operations as adverse event reporting and assessment of clinical supplies.

Sites may need to augment their existing staff to get trials up and running as quickly as possible, Cioffi says. Temporary staff can be brought in to fill in the gaps in emergency situations. For instance, remote study coordinators can step in to replace site staff that may be reassigned to clinical care or unavailable to work. 

Remote coordinators can handle a variety of tasks for an ongoing trial, including performing remote data entry, handling query resolution, processing safety reports and supporting source document creation. For a trial that has been stalled or is not able to start, they can help maintain forward progress by helping with feasibility and startup documentation, screening and educating potential trial participants, and reviewing patient charts to build a pool of potential participants.

WCG ThreeWire presents one example of how this kind of site support can keep a study on schedule. When Hurricane Harvey struck Texas in 2017 and made transportation difficult for staff and patients in a multisite trial covering several states, ThreeWire’s remote coordinators were able to arrange ride-sharing services so patients wouldn’t miss visits and site staff could continue trial operations.⁴ 

Three years later, faced with the COVID-19 crisis, the same top-10 pharma sponsor asked the company to reach out to each of its sites across the globe to offer remote support.

Impact of safety measures

Along with the need for increased staffing, COVID-19 presents challenges for keeping staff, as well as patients, safe. Extra safety precautions often require more staff effort to implement. For example, Benchmark Research, which has clinical sites in Texas, California and Louisiana, has instituted a patient greeting program that adds an extra step to visits. When patients arrive at the site, they’re met by a greeter behind plexiglass who takes the patient’s temperature and asks a series of questions about potential COVID exposure.⁵

Benchmark sites also have removed unnecessary furniture from waiting rooms to ensure patients keep six feet between them, according to Benchmark CEO and President Mark Lacy. Sites have also purchased walkie-talkies so that staff can be in communication about how many people are in the facility at any one time.

Researchers Mary McDermott and Anne Newman offered suggestions on how to keep patients from crowding into sites as trials reopen as well as how to limit possible staff exposure in a March 2020 JAMA article.⁶ Tactics for distancing could include administering questionnaires by telephone and collecting objective outcomes at home when feasible and safe or off-site where possible exposure can be minimized. 

Eligibility screening can take place over the phone and those chosen to participate can attend site visits later, added McDermott, the Jeremiah Stamler Professor and professor of General Internal Medicine and Geriatrics at Northwestern University in Chicago, and Newman, professor and chair of the Department of Epidemiology in the Graduate School of Public Health at the University of Pittsburgh. 

Distancing of staff members themselves may also be necessary when trials restart. Children’s Hospital of Philadelphia (CHOP) has initiated specific physical distance guidelines. For example, they’re allowing adjacent 6-by-6 foot workstations, but staff may not sit facing each other and they’ve blocked off parts of other work areas, as well. The hospital also has called for for six-foot physical distancing in all common areas and also said no more than four individuals may ride an elevator at one time.⁷  

CHOP does not expect that normal activities will ever return: “It is not clear whether or when we will ‘return to normal.’ Research teams should plan on ... maintaining physical distancing for the foreseeable future.”

Sites must minimize risk for both participants and staff, Tom Wardle, CEO of CenExel Clinical Research, said in a May 2020 WCG Clinical webinar. Study participants should be educated about precautions during prescreening telephone interviews, every time they enter the facility for a visit and at enrollment. Sites must give enrollees and staff continuous reminders about the importance of using personal protective equipment (PPE).⁸  

Sites should also minimize the risk of infection at their facilities, Wardle said. Some best practices were standard before the pandemic while others will likely become the standard going forward. 

For example, Wardle explained, sites must create and focus on:

• Pandemic-specific standard operating procedures (SOPs). These SOPs should include use of PPE, procedures for entering the facility and testing procedures, for example.
• Remote monitoring procedures. The site should make clear how to stay in contact with patients between outpatient visits and while they are on inpatient units, Wardle said.
• Remote visit procedures. “When applicable, sites should develop study-specific plans (following FDA and IRB guidance) for remote visits of patients,” he added.
• Current CDC infection control guidelines. Note that these guidelines change frequently, so researchers should stay abreast of developments.
• PCR (polymerase chain reaction) testing policies and procedures. Researchers must answer questions about when and how often patients should be tested for active COVID-19 infection, who is responsible for the cost of the testing and whether test results should be included in the study protocol.
• Site-specific changes in day-to-day activities. These include limiting the number of people in specific areas at once, screening staff daily, limiting access to the facility, sequestering symptomatic patients immediately and following infection control and facility cleaning guidelines, Wardle said.

Care and support

It’s also important to nurture and help staff cope in difficult times, said Edward Jones, president and CEO of Houston Methodist Research Institute, at the same webinar.

Site managers must take into account and do what they can to plan for and address the following:

• Symptoms of fatigue and fear among staff who may be exhausted and overwhelmed;
• Confusion about misalignment of local, state and federal policies; 
• Requirements for safe but efficient staffing levels amidst social distancing requirements;
• Considerations about access to dependent and childcare, which could prevent some staff from returning;
• Cross-functional resources and considerations about how a site can balance the need for staff in COVID-19-related research with the need to return people to non-COVID activities.

With concerns that a second wave of infections will crop up later this year or that some areas of the country are still on an upward trajectory, Jones suggested researchers should assume that the presence of and challenges around COVID-19 will continue. “To do otherwise is just short-sighted,” he said.

Predicting staffing needs

It is possible to back up such assumptions with hard data and predict what staffing levels sites will need when facing a resurgence of the virus. Recent advances in the practice of data analytics have provided new tools that sites can use to ensure they have the staff they need on hand in all kinds of situations. 

Chief among them is predictive analytics, a method that can help sites plan ahead for disruptions — such as a global pandemic — by combining information about staffing and workflow in normal situations, then factoring in external forces that could increase staffing needs.

It’s been used to great effect in emergency healthcare settings, according to a June 2019 article in HealthTech, where unexpected events ranging from hurricanes to changes in bus schedules can increase the demand for service while decreasing the availability of staff to provide it.⁹

“We may figure out how to manage our average workloads, but how do we respond to surge capacity as well?” asks Kirk Jensen, chief innovation officer at Envision Physician Services and a 20-year veteran of emergency medicine management. Envision has developed a web-based, data-driven capacity management tool that helps define optimal staffing levels.

“We’ve had to get more sophisticated,” Jensen says. Historically, organizations called in the troops when staff and resources were overwhelmed. But “there’s a gap between the signal and the need,” he says. Staffers usually only realize they’re in over their heads after additional resources would have helped. 

“With analysis tools, we can shift some of that staffing further forward,” Jensen says. “There’s a tremendous opportunity here to optimize safety and make service improvements,” he says.

Organizations must have the ability, the time and the data to align it all, says Bill Orrell, managing director at Berkeley Research Group, in the same article. Organizations should examine their staffing numbers regularly, he says, suggesting a review of staff capacity every four to six months and any time something changes, such as a disease outbreak or changes in the weather.

“It’s more and more important,” he says, “that organizations are focused on aligning staffing to the volume and focusing on that throughput,” from greeting patients at the door to managing treatment throughout a trial.

Cost and return

A tool like predictive analytics requires an investment — money, time and training — but can return benefits in equal measure.

By planning for proper staffing, the method can help sites avoid staff burnout and focus on critical aspects of patient care and trial operations. “The return on that investment in time, energy and critical thinking is enormous,” Jensen says. 

At Bergen New Bridge Medical Center in Paramus, N.J., analytics is helping improve quality, better coordinate care, improve efficiency and optimize staffing. Accurately predicting patient ebbs and flows and using that data to inform staffing has allowed Bergen to make some practical and fairly simple changes that affect the organization’s bottom line, says Thomas Amitrano, Bergen’s chief nurse executive, in the HealthTech article.

“We ask who is showing up where, what kind of diagnoses are coming in and in what volume and acuity so that we can not only staff but staff appropriately,” Amitrano said. “The more data you have, the better, as long as you can put it into a framework that is actionable and that actually tells you something.” 

“Those are the type of analyses that this affords us that we didn’t have before,” he says. “For me, the excitement comes from how we look at delivering the care and what changes we can make to better the patient experience. This type of data helps us best prepare for who we care for.” 

Staff shortage, data shortage

One thing predictive analytics can’t help you with, however, is figuring out how to fill the gaps in trial data caused by disruptions like COVID-19.

“Could changes induced by the pandemic — including less consistent follow-up visits, reduced movement, poorer mental or physical health or infection with the novel coronavirus itself — blur the statistical signals of a treatment’s risks and benefits?” asked Science staff writer Kelly Servick in a May 6 article.¹⁰

Janet Dancey, leader of the Canadian Cancer Clinical Trials Network and the Canadian Cancer Trials Group, told Servick that she was, indeed, concerned.  

“We’re all going to have to plan for how we account for the impact of COVID” on participants and, by extension, their data, she said. Study participants could have become ill or died from the virus. 

Dancey said the infected patients could be distributed randomly between the trial’s treatment and control groups, but the effects could still be difficult to separate from any negative side effects of the study drug treatment. 

“If there are competing causes of death that are going on, then it will be harder to show differences in outcomes ... It reduces our power.”

Regarding the pandemic’s effects on data, Dancey suggested focusing on a study’s primary endpoint, trying to make data collection as complete as possible and documenting any deviations from the study plan. “We have to make sure that people are looked after — whether they’re patients with or without cancer or health care professionals,” she said. “And then we’ll look after the trial.”

Sites should prepare for missing data, according to Halloran Consulting’s Hannah Yee and Todd Johnson. “When thinking about your statistics strategy for missing data, remember to 1) collect what you can, 2) document what happened and 3) analyze,” they wrote in a Clinical Leader article.¹¹ For data collection, the emphasis should be on limiting the barriers for patients to provide required study data. 

Yee and Johnson emphasized that flexibility in collecting this data is critical. Missing data will be inevitable but must be documented and explained. Statisticians should run additional analyses around sensitivity, safety and treatment effects before, during and after COVID-19, they wrote. 

“For time-based comparison analyses, statisticians are relying upon site-level data when defining the start and finish of the pandemic, as conditions are highly dependent on locality.” 

Yee and Johnson also recommended that sponsors and sites run through a quality checklist specific to COVID-19-affected areas. The checklist should include a quality plan, or modifications to an existing quality plan, that “address actions taken during COVID-19 and continued risks that will need to be considered and mitigated.” 

In addition, it should include “a communications strategy covering internal leadership [and] teams, external partners [and] vendors, sites, study participants and regulatory agencies. The strategy should include timing, frequency and messaging content.”

Tips for weathering a storm

There are some tactics sites can use to ease operations when they are short-staffed or overburdened.

Jessica Lugo, clinical trial manager at ICON, offered recommendations for keeping projects flowing smoothly at the 2020 MAGI Clinical Research Cloud Conference in June.¹²

Communication is key, Lugo pointed out, especially in keeping all stakeholders informed of trial changes. And an overreliance on email actually can weaken communication channels, she said. “Not having those conference calls, not having the right people on the conference calls to discuss everything we need to discuss” makes decisionmaking more difficult.

Understanding priorities and workloads also is important, she said. A lack of clear objectives and a clear path leads to an overworked team. Each team also must be aware and respectful of other groups’ workloads and resource needs.

There are many stakeholders in a clinical trial with many different views and needs. Lugo said understanding competing priorities can help keep everyone coordinated, a particular necessity in the pandemic environment. “This is a big one,” she said, “especially for our current environment where we’re moving at lightning speed and we’re trying to do everything we would typically do in six months in a week.”

“None of us planned for this,” Lugo said. “I never had this on my risk tracker. So we are all having to scramble and get our resources together” to understand exactly what we need to do, she said.

“We’re having to pivot in ways we never thought we would have to.”

References

1. Ingram M. Restarting Clinical Trials Requires Planning for Costs, Staffing and Technology. The CenterWatch Monthly. https://www.centerwatch.com/articles/24806-restarting-clinical-trials-requiresplanning-for-costs-staffing-and-technology. Published July 1, 2020. Accessed July 8, 2020. 
2. Halloran L. Clinical Study Risk Management During The COVID-19 Pandemic. Clinical Leader. https://www.clinicalleader.com/doc/clinical-study-risk-management-during-the-covid-pandemic-0001. Published April 6, 2020. Accessed May 29, 2020.
3. Part 4: Planning for Recovery: How Research Sponsors and Research Sites are Thinking Ahead to Restart Research. WCG Clinical. https://www.wcgclinical.com/insights/covid-19-insights/clinical-trials-in-the-era-of-covid-19-part-4. Published April 8, 2020. Accessed June 24, 2020.
4. Save the Data. Protect the Patients. Prepare for What Comes Next: Remote Clinical Research Coordinators. WCG Clinical. https://www.wcgclinical.com/insights/whitepapers/virtual-site-support-covid19. Published 2020. Accessed June 24, 2020.
5. Ingram M. Restarting Clinical Trials Requires Planning for Costs, Staffing and Technology. The CenterWatch Monthly. https://www.centerwatch.com/articles/24806-restarting-clinical-trials-requiresplanning-for-costs-staffing-and-technology. Published July 1, 2020. Accessed July 8, 2020.
6. McDermott MM, Newman AB. Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. 2020;323(21):2135–2136. https://jamanetwork.com/journals/jama/fullarticle/2763819. Published March 25, 2020. Accessed June 24, 2020. 
7. FAQs for Clinical Research During the Coronavirus Pandemic. (n.d.). Children’s Hospital of Philadelphia Research Institute. https://www.research.chop.edu/announcements/faqs-for-clinical-research-during-the-coronavirus-pandemic. Published June 16, 2020. Accessed June 24, 2020.
8. Part 8. The Realities of Restart. WCG Clinical. https://www.wcgclinical.com/insights/covid-19-insights/clinical-trials-in-the-era-of-covid-19-part-8. Published May 6, 2020. Accessed June 24, 2020.
9. Shaw G. How Emergency Departments Can Use Predictive Analytics to Optimize Staffing. HealthTech. https://healthtechmagazine.net/article/2019/06/how-emergency-departments-can-use-predictive-analytics-optimize-staffing-perfcon. Published June 26, 2019. Accessed June 24, 2020.
10. Servick K. Clinical trials press on for conditions other than COVID-19. Will the pandemic's effects sneak into their data? Science. https://www.sciencemag.org/news/2020/05/clinical-trials-press-conditions-other-covid-19-will-pandemic-s-effects-sneak-their. Published May 7, 2020. Accessed June 19, 2020.
11. Yee H, Johnson T. Developing A Clinical Trials Strategy for a Post-COVID World. https://www.clinicalleader.com/doc/developing-a-clinical-trials-strategy-for-a-post-covid-world-0001. Published May 4, 2020. Accessed May 26, 2020.
12. Setting and Managing Priorities in a Clinical Project Schedule. MAGI. https://www.magiworld.org/mysessionpage?ESPK=14101. Published June 25, 2020. Accessed June 25, 2020.